
Merck has issued revised labeling for its COX-2 inhibitor rofecoxib (Vioxx) that incorporate findings from the 8,000-patient VIGOR (Vioxx Gastrointestinal Outcomes Research) study.

Merck has issued revised labeling for its COX-2 inhibitor rofecoxib (Vioxx) that incorporate findings from the 8,000-patient VIGOR (Vioxx Gastrointestinal Outcomes Research) study.

New contraindications and precautions have been added to the labeling of methylphenidate HCl tablets (Ritalin and Ritalin-SR, Novartis)-approved for treatment of attention deficit/hyperactivity disorder (ADHD).

Enoxaparin sodium (Lovenox injection, Aventis) is not recommended for thromboprophylaxis in patients with prosthetic heart values and particularly in pregnant women with prosthetic heart valves, according to revised product labeling.

A new black box warning has been added to the labeling of all interferon alfa products (Intron A, Rebetron, Roferon-A).

Pfizer has issued a "Dear Healthcare Professional" letter to clarify and strengthen contraindications with its antipsychotic agent ziprasidone HCl (Geodon).

From Consumer Advocy Groups:Public Citizen urges ban on Arava. . . According to Public Citizen, 130 cases of severe liver toxicity-including 56 hospitalizations and 12 deaths-have been reported to the FDA since the 1998 introduction of rheumatoid arthritis agent leflunomide (Arava). This equates to six times the number of cases of fatal liver toxicity seen with methotrexate, although 5.5 times more prescriptions for methotrexate were filled over the 3-year comparative period. Public Citizen also says that leflunomide has been associated with 12 cases of Stevens-Johnson syndrome (compared with none reported with methotrexate) and more reports of lymphoma and hypertension.

Ratherthan shortening the hospital stay and improving clinical outcomes, a 48-hour infusion of milrinone was associated with increased early treatment failure-particularly due to the development of arrhythmias and hypotension-in patients hospitalized with acute exacerbations of chronic heart failure (CHF).

as reported May 1, 2002

Enoxaparin (Lovenox) is typically used during hospitalization after orthopedic or abdominal surgery. Recent studies of its use after orthopedic surgery have shown that extending administration of the low-molecular-weight heparin after hospital discharge significantly reduces the frequency of deep-vein thrombosis (DVT). A new study confirms this is also the case for abdominal surgery for cancer, which carries a high risk of this complication.

Neither extracts of Hypericum perforatum (St. John's Wort) nor sertraline (Zoloft) tested in patients with major depressive disorder performed better than placebo in reducing patients' scores on a standard assessment of depression severity.

The investigational vasopeptidase inhibitor omapatrilat is as effective as enalapril in preventing major adverse cardiac outcomes in patients with moderate to severe heart failure, but failed to show superiority, said Milton Packer, MD.

LIPS: Statin reduces cardiac event risk by 22% in first PCI procedureAzithromax ineffective for reducing recurrent CV events

Even when very elderly (age 80 years and older)patients have no contraindications to thrombolytic therapy, treatment withthese drugs can increase their risk of death.

as reported May 1, 2002

Drug therapy to control heart rate is at least as effective as antiarrhythmicdrug therapy in preventing adverse clinical events in patients with atrialfibrillation (AF), according to separate studies.

Therapy starting with the angiotensin receptor blocker (ARB) losartansignificantly reduced the risk of cardiovascular outcomes and new-onsetdiabetes compared with a beta blocker in older high-risk hypertensive patients,said Björn Dahl öf, MD. The improved outcomes with losartan occurredeven after adjusting for small differences in blood pressure reduction betweenthe two study drugs.

Atlanta-The low-molecular-weight heparin enoxaparin improves outcomes compared with currently recommended therapy in patients with non-ST-segment elevation acute coronary syndromes (ACS) who are being treated with a glycoprotein (GP) IIb/IIIa inhibitor, said Shaun Goodman, MD.

Lercanidipine is currently under FDA review for the management of hypertension. In comparative clinical trials, lercanidipine has shown antihypertensive efficacy comparable to that of slow-release nifedipine, amlodipine, nitrendipine, verapamil, captopril, and atenolol. Its side effect profile is similar or superior to these agents. This Focus article reviews those trials as well as lercanidipine?s pharmacologic properties and addresses the agent?s potential role in patients with comorbid conditions.

Although selective serotonin reuptake inhibitors (SSRIs) are prescribed most often for depression disorders, they are increasingly being used to treat a variety of other conditions. In this article, the authors assess the evidence on anxiety disorders—generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and social phobia. For each condition, they present the rationale for SSRI use, the degree of supportive clinical trial evidence, indication-specific dosing and safety considerations, and their recommendations for the preferred and alternative SSRIs.

Adding the investigational cholesterol absorption inhibitor ezetimibe to statin therapy results in additional reductions in low-density lipoprotein (LDL) cholesterol of up to 14%.

There is is a rising chorus in Washington and across the nation for action to control increased prescription drug expenditures.

The American Psychiatric Association has issued updated guidelines for the treatment of patients with bipolar disorder. The guidelines were last updated in 1994.

Last month the FDA's Nonprescription Drugs Advisory Committee unanimously supported loratadine's (Claritin, Schering-Plough) switch from prescription to over-the-counter status for treatment of chronic idiopathic urticaria, moving the drug one step closer to full OTC status (see significant event timeline in sidebar).

First time generics

Atopic dermatitis is a chronic, recurrent skin disease characterized by intense pruritis (itching) and inflammation. This supplement which was produced through an unrestricted educational grant from Fujisawa Healthcare, Inc. provides you with an overview of the disease and the development of Topic Immunomodulators. The views and opinions expressed in this supplement do not necessarily reflect the views of Formulary.

While the Bush administration persists in promoting a Medicare RxDrug Card plan, pharmaceutical companies continue to unveil their own versions.